Heterotopic Gastric Mucosa of the Proximal EsophagusSYM-HGMNCT07510984
Symptoms and Quality of Life in Patients With Heterotopic Gastric Mucosa (HGM)
An observational study of Heterotopic Gastric Mucosa of the Proximal Esophagus and Gastric Inlet Patches, run by Knappschaft Kliniken GmbH at 1 site in Germany.
Trial summary
The goal of this observational study is to learn whether heterotopic gastric mucosa (HGM) in the upper esophagus is associated with swallowing difficulties (dysphagia) in adults undergoing a medically indicated gastroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heterotopic Gastric Mucosa of the Proximal Esophagus, Gastric Inlet Patches, Dysphagia
- How many people
- 721 participants
- Where
- 1 siteGermany
- Study dates
- 24 Mar 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years) undergoing clinically indicated upper gastrointestinal endoscopy (gastroscopy) at a single center will be consecutively screened and invited to participate over a 12-month period. After informed consent, participants complete symptom and health-related quality-of-life questionnaires prior to endoscopy. During routine gastroscopy, the presence or absence of heterotopic gastric mucosa (HGM) in the proximal esophagus is assessed based on endoscopic appearance (and histology from routine care if available). Participants are grouped as HGM present vs no HGM for comparative analyses.
Who may be able to join
- Planned upper gastrointestinal endoscopy (gastroscopy) for clinical reasons (any indication)
- Age ≥ 18 years
- Written informed consent
- Ability to complete the study questionnaires prior to endoscopy
Who cannot join
- Previously known heterotopic gastric mucosa (HGM)
- Previously diagnosed dysphagia with prior therapeutic intervention (including pre-established diet modification, partial oral/enteral nutrition, steroid therapy, botulinum toxin injection, etc.)
- Mechanical ventilation
- Presence of a tracheostomy
- Inadequate endoscopic assessability of the proximal esophagus, including:
- General condition insufficient for careful endoscopic inspection (investigator's judgement)
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- Increased risk of aspiration
- Inadequate visibility during the procedure (e.g., bleeding, food residue)
- Complications preventing careful inspection of the proximal esophagus
- History of surgery involving the pharynx or esophagus
- Relevant severe neurological disorder (e.g., ALS, stroke)
- Severe dementia
- Severe depressive disorder
- Lack of cooperation / inability to comply with study procedures
- Planned PEG placement
- Emergency endoscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Knappschaftskrankenhaus Bottrop
Bottrop, North Rhine-Westphalia, 46240
Felix Horstmann, MD, +492041151501, felix.horstmann@kjnappschft-kliniken.de
Thorsten Brechmann, Priv.-Doz. Dr.med, MD, +492041151500, thorsten.brechmann@rub.de
About this study
Official title: Prevalence and Characterization of Dysphagia and Dyspepsia Symptoms and Assessment of Quality of Life in Heterotopic Gastric Mucosa (HGM)
The goal of this observational study is to learn whether heterotopic gastric mucosa (HGM) in the upper esophagus is associated with swallowing difficulties (dysphagia) in adults undergoing a medically indicated gastroscopy. The main questions it aims to answer are:
- Is the presence of HGM associated with dysphagia?
- Is the presence of HGM associated with dyspepsia and reduced health-related quality of life? Among participants reporting dysphagia, what is the distribution of oropharyngeal versus esophageal dysphagia, and is this related to the presence of HGM? If there is a comparison group: Researchers will compare participants with endoscopically confirmed HGM to participants without HGM to determine whether dysphagia, dyspepsia symptoms, and quality-of-life measures differ between groups.
Read more
Participants will:
Complete pseudonymised questionnaires about dysphagia, dyspepsia symptoms, and quality of life before the gastroscopy.
Undergo the medically indicated gastroscopy as planned; the endoscopist will assess whether HGM is present based on the endoscopic appearance, and routine endoscopy findings will be documented.
Read the detailed description
Heterotopic gastric mucosa (HGM) consists of islands of gastric-type mucosa located in the proximal esophagus, typically just below the upper esophageal sphincter. HGM is frequently detected incidentally during upper GI endoscopy, and its clinical relevance remains incompletely understood. Retrospective data suggest that HGM may be associated with symptoms such as dysphagia and dyspepsia; however, prospective data and information on health-related quality of life are limited.
This is a prospective, observational, single-center study conducted in adults (≥18 years) undergoing clinically indicated gastroscopy for any indication. The primary objective is to investigate the association between HGM and dysphagia. Secondary objectives are to evaluate associations between HGM and dyspepsia and impairment of quality of life, and to differentiate oropharyngeal versus esophageal dysphagia. An additional exploratory objective is to assess whether symptom patterns vary by histological subtype when histology is available from routine care.
After informed consent, participants complete paper-based, pseudonymised questionnaires prior to endoscopy (estimated completion time ~30-45 minutes). Oropharyngeal dysphagia is assessed using the Sydney Swallowing Questionnaire (SSQ, German version), and esophageal dysphagia using the Eating Assessment Tool-10 (EAT-10, German version). Dysphagia-related quality of life is assessed with the M.D. Anderson Dysphagia Inventory (MDADI, German validated version/D-ADI). Dyspepsia symptom burden and related quality of life are assessed using the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD). The endoscopist is blinded to questionnaire results. During routine gastroscopy, the proximal esophagus is carefully inspected (preferably using Narrow Band Imaging) and the presence or absence of HGM is documented; participants are assigned to HGM or control (no HGM) groups. No additional procedures are mandated by the study; routine endoscopy and any clinically indicated histology are recorded as available.
Data are collected and stored in pseudonymised form and analyzed statistically (planned recruitment period ~12 months). The anticipated total sample size is 731 participants.
- Conditions
- Heterotopic Gastric Mucosa of the Proximal Esophagus, Gastric Inlet Patches, Dysphagia, Dyspepsia
- Keywords
- Cervical Esophagus, Proximal Esophagus, Upper Endoscopy, Oropharyngeal Dysphagia, Eophageal Dysphagia, Sidney Swallowing Questionnaire, EAT-10, MDADI, GSRS, QOLRAD, Narrow Band Imaging, Quality of Life
- Medical subject headings
- Deglutition Disorders, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HGM present | Participants with endoscopic evidence of heterotrophic gastric mucosa | |
| No HGM | Participants without endoscopic evidence of heterotrophic gastric mucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia Symptom Burdon (EAT-10 und SSQ)
Dysphagia symptom burden is assessed using two patient-reported questionnaires completed prior to medically indicated gastroscopy: (1) the Sydney Swallow Questionnaire (SSQ/SSQ-G) and (2) the Eating Assessment Tool-10 (EAT-10). The SSQ total score ranges from 0 to 1700 (higher scores indicate worse swallowing-related symptoms); for descriptive/binary analyses, an SSQ-G total score >234 is considered outside the normative range (pathological). The EAT-10 total score ranges from 0 to 40 (10 items scored 0-4; higher scores indicate greater dysphagia burden); an EAT-10 total score ≥3 is considered abnormal (indicative of dysphagia). Comparative analyses will be performed between participants with endoscopically detected heterotopic gastric mucosa (HGM) and participants without HGM.
Measured: Baseline (prior to gastroscopy; single assessment at enrollment)
Secondary outcomes (3)
HGM & Dyspepsia (GSRS)
Dyspepsia symptom burden assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item patient-reported questionnaire referring to symptoms during the past week. Items are rated on a 7-point Likert scale from 1 (no discomfort) to 7 (very severe discomfort); higher scores indicate worse symptoms. GSRS domain scores (mean of items within the domain) will be analyzed, focusing on the Indigestion and Abdominal Pain domains as dyspepsia-related measures. As there is no universally defined clinical cut-off for GSRS, a score ≥4 (at least moderate symptom severity) may be used for descriptive/binary analyses. Comparison between participants with endoscopically detected HGM vs participants without HGM.
Measured: Baseline (prior to gastroscopy; single assessment at enrollment)
Type of Dysphagia (Oropharyngeal vs Esophageal)
Classification of dysphagia phenotype as oropharyngeal versus esophageal based on participant-reported symptom patterns captured in the Sydney Swallow Questionnaire (SSQ/SSQ-G) and the Eating Assessment Tool-10 (EAT-10), completed prior to medically indicated gastroscopy. The distribution of dysphagia type (oropharyngeal vs esophageal) will be compared between participants with endoscopically detected heterotopic gastric mucosa (HGM) and participants without HGM. Abnormal dysphagia symptom burden is defined as SSQ-G total score >234 and/or EAT-10 total score ≥3.
Measured: Baseline (prior to gastroscopy; single assessment at enrollment)
Health-Related Quality of Life (HRQoL)
Health-related quality of life (HRQoL) is assessed using two disease-specific patient-reported questionnaires completed prior to medically indicated gastroscopy: (1) the German version of the M.D. Anderson Dysphagia Inventory (MDADI-D / A-ADI) to quantify swallowing-related quality of life, and (2) the German version of the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) to quantify reflux/dyspepsia-related quality of life. The MDADI-D/A-ADI composite score is linearly transformed to a scale of 20-100, with higher scores indicating better swallowing-related HRQoL; for descriptive/binary analyses, MDADI-D/A-ADI composite score <60 may be considered poor (moderate-to-severe impairment). QOLRAD items are rated on a 7-point Likert scale (1-7), with lower scores indicating worse HRQoL; domain scores (mean of items within each domain) and/or an overall mean score will be analyzed. As there is no universally established clinical cut-off for QOLRAD, a pragmatic threshold of QOL
Measured: Baseline (prior to gastroscopy; single assessment at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start24 Mar 2026
- Primary completion24 Mar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterotopic Gastric Mucosa of the Proximal EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 721 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Knappschaft Kliniken GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Horstmann, Knappschaft Kliniken GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510984
- Sponsor's protocol ID
- SYM-HGM-01
- Other IDs
- DRKS00039148
- Acronym
- SYM-HGM
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Only aggregated results will be published; data access is restricted due to data protection requirements and the wording of the informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Characterization of Dysphagia and Dyspepsia Symptoms and Assessment of Quality of Life in Heterotopic Gastric Mucosa (HGM)
- ClinicalTrials.gov ID
- NCT07510984
- Acronym / sponsor ID
- SYM-HGM / SYM-HGM-01
- Conditions
- Heterotopic Gastric Mucosa of the Proximal Esophagus, Gastric Inlet Patches, Dysphagia, Dyspepsia
- Keywords
- Cervical Esophagus, Proximal Esophagus, Upper Endoscopy, Oropharyngeal Dysphagia, Eophageal Dysphagia, Sidney Swallowing Questionnaire, EAT-10, MDADI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 721 participants (estimated)
- Lead sponsor
- Knappschaft Kliniken GmbHUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 24 Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn whether heterotopic gastric mucosa (HGM) in the upper esophagus is associated with swallowing difficulties (dysphagia) in adults undergoing a medically indicated gastroscopy. The main questions it aims to answer are:
- Is the presence of HGM associated with dysphagia?
- Is the presence of HGM associated with dyspepsia and reduced health-related quality of life? Among participants reporting dysphagia, what is the distribution of oropharyngeal versus esophageal dysphagia, and is this related to the presence of HGM? If there is a comparison group: Researchers will compare participants with endoscopically confirmed HGM to participants without HGM to determine whether dysphagia, dyspepsia symptoms, and quality-of-life measures differ between groups.
Participants will:
Complete pseudonymised questionnaires about dysphagia, dyspepsia symptoms, and quality of life before the gastroscopy.
Undergo the medically indicated gastroscopy as planned; the endoscopist will assess whether HGM is present based on the endoscopic appearance, and routine endoscopy findings will be documented.
Detailed description
Heterotopic gastric mucosa (HGM) consists of islands of gastric-type mucosa located in the proximal esophagus, typically just below the upper esophageal sphincter. HGM is frequently detected incidentally during upper GI endoscopy, and its clinical relevance remains incompletely understood. Retrospective data suggest that HGM may be associated with symptoms such as dysphagia and dyspepsia; however, prospective data and information on health-related quality of life are limited.
This is a prospective, observational, single-center study conducted in adults (≥18 years) undergoing clinically indicated gastroscopy for any indication. The primary objective is to investigate the association between HGM and dysphagia. Secondary objectives are to evaluate associations between HGM and dyspepsia and impairment of quality of life, and to differentiate oropharyngeal versus esophageal dysphagia. An additional exploratory objective is to assess whether symptom patterns vary by histological subtype when histology is available from routine care.
After informed consent, participants complete paper-based, pseudonymised questionnaires prior to endoscopy (estimated completion time ~30-45 minutes). Oropharyngeal dysphagia is assessed using the Sydney Swallowing Questionnaire (SSQ, German version), and esophageal dysphagia using the Eating Assessment Tool-10 (EAT-10, German version). Dysphagia-related quality of life is assessed with the M.D. Anderson Dysphagia Inventory (MDADI, German validated version/D-ADI). Dyspepsia symptom burden and related quality of life are assessed using the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD). The endoscopist is blinded to questionnaire results. During routine gastroscopy, the proximal esophagus is carefully inspected (preferably using Narrow Band Imaging) and the presence or absence of HGM is documented; participants are assigned to HGM or control (no HGM) groups. No additional procedures are mandated by the study; routine endoscopy and any clinically indicated histology are recorded as available.
Data are collected and stored in pseudonymised form and analyzed statistically (planned recruitment period ~12 months). The anticipated total sample size is 731 participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HGM present | – | –Participants with endoscopic evidence of heterotrophic gastric mucosa |
| No HGM | – | –Participants without endoscopic evidence of heterotrophic gastric mucosa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) undergoing clinically indicated upper gastrointestinal endoscopy (gastroscopy) at a single center will be consecutively screened and invited to participate over a 12-month period. After informed consent, participants complete symptom and health-related quality-of-life questionnaires prior to endoscopy. During routine gastroscopy, the presence or absence of heterotopic gastric mucosa (HGM) in the proximal esophagus is assessed based on endoscopic appearance (and histology from routine care if available). Participants are grouped as HGM present vs no HGM for comparative analyses.
Key inclusion criteria (4 listed)
- Planned upper gastrointestinal endoscopy (gastroscopy) for clinical reasons (any indication)
- Age ≥ 18 years
- Written informed consent
- Ability to complete the study questionnaires prior to endoscopy
Key exclusion criteria (16 listed)
- Previously known heterotopic gastric mucosa (HGM)
- Previously diagnosed dysphagia with prior therapeutic intervention (including pre-established diet modification, partial oral/enteral nutrition, steroid therapy, botulinum toxin injection, etc.)
- Mechanical ventilation
- Presence of a tracheostomy
- Inadequate endoscopic assessability of the proximal esophagus, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dysphagia Symptom Burdon (EAT-10 und SSQ)
Time frame: Baseline (prior to gastroscopy; single assessment at enrollment)
Dysphagia symptom burden is assessed using two patient-reported questionnaires completed prior to medically indicated gastroscopy: (1) the Sydney Swallow Questionnaire (SSQ/SSQ-G) and (2) the Eating Assessment Tool-10 (EAT-10). The SSQ total score ranges from 0 to 1700 (higher scores indicate worse swallowing-related symptoms); for descriptive/binary analyses, an SSQ-G total score >234 is considered outside the normative range (pathological). The EAT-10 total score ranges from 0 to 40 (10 items scored 0-4; higher scores indicate greater dysphagia burden); an EAT-10 total score ≥3 is considered abnormal (indicative of dysphagia). Comparative analyses will be performed between participants with endoscopically detected heterotopic gastric mucosa (HGM) and participants without HGM.
3 secondary outcomes
HGM & Dyspepsia (GSRS)
Time frame: Baseline (prior to gastroscopy; single assessment at enrollment)
Type of Dysphagia (Oropharyngeal vs Esophageal)
Time frame: Baseline (prior to gastroscopy; single assessment at enrollment)
Health-Related Quality of Life (HRQoL)
Time frame: Baseline (prior to gastroscopy; single assessment at enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Only aggregated results will be published; data access is restricted due to data protection requirements and the wording of the informed consent.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heterotopic Gastric Mucosa of the Proximal Esophagus and Gastric Inlet Patches, run by Knappschaft Kliniken GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Horstmann, MD (02041151500, felix.horstmann@knappschaft-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia Symptom Burdon (EAT-10 und SSQ) (time frame: Baseline (prior to gastroscopy; single assessment at enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.